Colostomy appliance adhesive patch for fastening same to the body

ABSTRACT

This invention relates to a double-faced adhesive patch of nonwoven fibrous material particularly well suited for use as a means for temporarily fastening medical appliances and the like to the skin. The patch is characterized by a coating of a nondrying pressure sensitive adhesive on both sides of the fabric that remains covered and thus protected until ready for use by a conventional silicon-impregnated paper rip-strip that forms a laminate therewith. The invention also encompasses the method of making the laminate which consists of coating the releasable surfaces of the silicone-coated rip-strips with the pressuresensitive non-drying adhesive preparatory to sandwiching the base uncoated fabric therebetween. The invention additionally includes a colostomy appliance consisting of a slightly modified form of the patch permanently glued to the rear face of a side-pleated expandable polyethylene bag having a foldable flap at the bottom and permanently folded flap at the top, the outer layer of which can be turned inside out.

United States Patent [191 Trousil 1 1 Aug. 5, 1975 [76] Inventor: RobertE. Trousil. l95 Continental View Dr.. Boulder. Colo. 8113113 [22] Filed:July 30. I973 [21] Appl. N0.: 384,016

[52] US. Cl. 128/283; 128/295; 128/156 {51] Int. Cl. Ablf 5/44 [58]Field of Search 161/167. DIG. 6; 128/227.

128/283, 294.295, 156. DIG. 24'. 229/53, 62. 66. DIG. 3. DIG. 13;150/.5. l-7

[56] References Cited UNITED STATES PATENTS 2.543.299 2/1951 Pritchard150/7 2.709.467 5/1955 Hoeppner 150/7 2.721.553 10/1955 Perry 128/2833.055.368 9/1962 Baxter 128/283 3.121.021 2/1964 Copeland. 128/1563.364.063 1/1968 Satas 123/156 3.366.116 1/1968 Huck 128/295 3.683.9188/1972 Pizzella 128/283 Primary E.\uminerRiChard A. Gaudet Ass/smutl;'.\tum'nerHenry S. Layton Attorney. Agent. or Firm-Edwin L. Spangler,.lr.

l 5 7 1 ABSTRACT This invention relates to a doublefaced adhesive patchof non-woven fibrous material particularly well suited for use as ameans for temporarily fastening medical appliances and the like to theskin. The patch is characterized by a coating of a non-drying pressuresensitive adhesive on both sides of the fabric that remains covered andthus protected until ready for use by a conventional silicon-impregnatedpaper rip-strip that forms a laminate therewith. The invention alsoencompasses the method of making the laminate which consists of coatingthe releasable surfaces of the silicone-coated rip-strips with thepressure-sensitive non-drying adhesive preparatory to sandwiching thebase uncoated fabric thcrebetween. The invention additionally includes acolostomy appliance consisting of a slightly modified form of the patchpermanently glued to the rear face of a side-pleated expandablepolyethylene bag having a foldable flap at the bottom and permanentlyfolded flap at the top. the outer layer of which can be turned insideout.

4 Claims. 5 Drawing Figures PATENTED AUG 75 COLOSTOMY APPLIANCE ADHESIVEPATCH FOR FASTENING SAME TO THE BODY Surgical procedures such as, forexample, circumostomies. colostomies. cutaneous ureterostomies,illeostomies and the like result in the patient being provided with anew waste material outlet or stoma in the body as a result of having hadto by-pass the natural openings either temporarily or permanently. inorder to handle the body waste discharge through said stoma, it becomesnecessary to temporarily attach a bag or other suitable receptacle inposition to receive same as the patient is left without any naturalability to control such emissions. Accordingly, the patient is providedwith what is known as a colostomy appliance that consists of adisposable plastic bag openable and reclosable at its lower end and somemeans for temporarily fastening same to the body so that the inletthereto registers with the surgicallyproduced stoma and is sealedtherearound. Ordinarily, these appliances remain affixed to the bodyonly a relatively short time before they come off and have to bereplaced with a fresh one. some people, in fact, experience considerabledifficulty in getting the appliances to adhere at all to their skinwhile others are subject to considerable irritation of the skin areabordering the opening due to the presence of the appliance. Even so,generally speaking, a patient tries to keep the appliance on as long aspossible because of the difficulty and inconvenience occasioned byhaving to change same.

The prior art colostomy appliances leave much to be desired in the wayof convenience, comfort, reliability, lack of irritation, sanitation andability to stay in place for prolonged periods of use. Several methodsare currently employed to fasten the bags in place over the stomaopening into the colon, one of the most widely used being that ofstrapping, glueing or otherwise fastening a flexible yet essentiallynon-elastic and fluidimpervious carrier to the skin with an openingtherein registering with the surgically-created stoma and then hanging adisposable plastic bag from such carrier. Proper sealing of the carrierto the skin is most difficult to achieve, especially when thenon-elastic nature of the carrier will not accommodate the stretching ofthe skin therebeneath that takes place even with ordinary body motionsuch as that occasioned by breathing, walking, bending and otheractivities that are anything but hyperactive. Also, the imperviousnature of the car rier is such that many persons experience severe skinirritation due to lack of air circulation, perspiration, the presence ofthe sealant or adhesive and the reaction to the body wastes which aredifficult, if not impossible, to effectively isolate.

Conversely, the use of a carrier has the advantage over the practice offastening the appliance directly to the body in that the carrier neednot be removed every time the bag is changed and, therefore, it becomesin a sense, semi-permanent; whereas, the directlyattached bag is, atbest, highly temporary and must, by its very nature, be changed atfrequent intervals. Nevertheless, the bag adapted for direct attachmentto the body has certain distinct advantages of its own. To begin with,it is far better able to accommodate flexion of the skin therebeneathalthough it still leaves much to be desired in this connection and stillsuffers from the disadvantage of not being able to breath, i.e. allowair to circulate between the bag and the body. Accordingly, skinirritation remains very much a problem and, in fact, it may well beheightened in severity due to the necessity for changing same morefrequently.

The bags themselves are, likewise. something less than ideal in thatthey rarely, if ever, provide a resealable opening in the top which someusers find most convenient for purposes of periodic irrigation andinspection as well as the occasional introduction of deodorants andother additives. The bags should lay flat against the body. yet, expandas needed to accept the waste products. Most important, however, is thefact that the appliance including the bag should be able to withstandconsiderable handling while remaining capable of being resealed and allwithout becoming unfastened from the body.

lt has now been found in accordance with the teaching of the instantinvention that these and other shortcomings of the prior art colostomyappliances, both those using a carrier and those without, can, in largemeasure, be overcome through the use of a novel and improveddouble-faced adhesive-coated non-woven fabric patch that can either beused to attach the carrier to the body or alternatively, the bag itself.The nonwoven fabric, while extremely thin, allows air to reach the skindue to the random arrangement of the fibers. Even more significant,however, is the ability of the fabric to bend, stretch and otherwiseconform and de form to whatever extent required to accommodate thecontours of the body as well as the movement of the skin therebeneatheven under active conditions. Both of these factors contribute to thecomfort of the appliance, greatly increase its retention properties,reduce skin irritation and otherwise lessen the burdens andinconvenience associated with having to wear same. all withoutdetracting in any way with the function performed thereby.

Furthermore, an improved appliance has been discovered which, inaddition to the aforementioned patch for fastening same directly to thebody, has a novel side-pleated expandable bag provided with apermanently-folded flap along the opening in the top that includes anouter layer which can be turned inside out to define a marginal cuffbordering said opening that can be reclosed.

Finally, a unique method of making the patch has been discoveredwherein, instead of coating both sides of the non-woven fabric with thepressure-sensitive non-drying adhesive preparatory to overlaying samewith the silicone-coated rip-strips that form the protective covertherefor as would be expected, instead the releasable faces of theprotective covers are first coated with the adhesive and the bareuntreated fabric is subsequently sandwiched therebetween.

Accordingly, it is the principal object of the present invention toprovide a novel and improved colostomy appliance.

A second objective of the invention herein disclosed and claimed is theprovision of a special double-faced non-woven adhesive patch fordetachably fastening the appliance to the skin, either directly orthrough the medium of a suitable carrier forming a part thereof.

Another object is to provide a unique method for making the patch whicheliminates the problems associated with having to directly coat bothsides of the non-woven fabric with adhesive.

Still another objective of the within described invention is theprovision of an adhesively-attached colostomy appliance wherein the bagis provided with side pleats and a reclosable and resealable opening inthe top thereof.

Some additional objects of the invention forming the subject matterhereof are to provide a colostomy appliance that is comfortable,versatile, reliable, compact, safe to use, sanitary, completelydisposable, easy to clean, simple to operate and quite inexpensive.

Further objects are to provide a double-faced patch of non-wovenmaterial coated on both sides with a nondrying pressure sensitiveadhesive that can be fastened to the skin, yet which is non-irritating,secure, easy to affix and remove, porous, flexible as well asstretchable to the degree required to accommodate movement of the skintherebeneath, simple to manufacture, lightweight, soft, breathable andreadily adapted for use with various types, styles and designs ofmedical appliances that must be detachably fastened to the patient.

Other objects will be in part apparent and in part pointed outspecifically hereinafter in connection with the description of thedrawings that follows, and in which:

FIG. 1 is a perspective view looking down and to the right upon the rearof the colostomy appliance prior to complete removal of the protectiverelease paper in the back of the double-faced adhesive patch;

FIG. 2 is a front elevation showing the flaps at both ends, the one atthe bottom being partially unfolded while the one at the top is brokenaway to better reveal the construction thereof;

FIG. 3 is a perspective view showing the back of the appliance as itwould be seen from a point above and to the right of its upper righthandcorner, the outer layer of the flap at the upper end having been shownturned inside out to open the top of the bag while cooperating with theinner layer to define a marginal cuff encircling the latter;

FIG. 4 is an exploded view of the carrier and a modi fied form of patchfor use therewith; and,

FIG. 5 is a schematic view illustrating the method of forming the patch.

Referring next to the drawings for a detailed description of the presentinvention and, initially, to FIGS. 1, 2 and 3 for this purpose,reference numeral has been chosen to broadly designate the colostomyappliance in its entirety while numeral I2 similarly designates alaminated subassembly affixed to the bag 14. This bag, in the particularform shown, comprises a polyethylene tube open at both its upper andlower ends that has been flattened and folded inwardly along both sidemargins in a manner to produce expansion pleats 16. Following formationof the pleats, the lower corners 18 are folded over on a 45 fold so asto bring the bottom margins 20 thereof into side-by-side parallelrealtion. Then, the isosceles triangle 22 (FIG. I) thus formed is foldedup along horizontal fold 24 and secured with a suitable fastener 26 toproduce the necessary sealed, but reopenably. fluidtight closure at thebottom.

The side pleats I6 do not extend all the way to the top of the bag, butinstead, are opened up as shown in FIG. I preparatory to folding overflap 28 along the top of the bag. Next. the side margins 30 of the flap28 are permanently heated-sealed to the corresponding margins 32 alongthe sides of the main body of the bag so as to define a common seam 34.With the flap 28 folded over and seamed as shown in FIGS. 1 and 2. thetop opening 36 in the bag is essentially scaled. To open same, the usergrasps the outer layer 38 of the flap and turns it inside out as shownin FIG. 3 thus producing a marginal cuff 40 around the open top of thebag. Removal of the fastener at the bottom allows the folded corners andbottom flap to be unfolded in the usual manner.

Directly underneath cuff 40 is permanently glued a laminated subassembly12 that includes a non-woven fibrous patch 42 with an opening 44 in thecenter thereof registering with a corresponding opening in the rear wall46 of the bag that is, in turn, placed over the stoma in the users body(not shown). The exposed face 48 of the patch is coated with apressure-sensitive nondrying adhesive protected until used by arip-strip S0 of silicone-coated paper or the like. If desired, a cornerof the exposed face of the patch can be left uncoated to facilitateremoval of the rip-strip or, alternatively, a permanent tab 52 can befastened thereto in the wellknown manner exemplified in FIG. 4. Whilethe patch is double-faced" in the sense that both sides areadhesive-coated, it is conceivable that the so-called hid den" face 54that lies against the bag could be coated with a permanent rather than anon-drying pressuresensitive adhesive like the exposed face provided, ofcourse, this could be done in such a way as to not interfere with thestripping action of the rip-strip and the novel manufacturing process tobe described presently. Accordingly, while this remains a possibility,the advantages attendant to using different types of adhesives on thehidden and exposed faces of the patch are so minimal when compared withusing the same nondrying pressure-sensitive adhesive on both that thelatter is much to be preferred.

While various formulations of non-drying pressuresensitive adhesiveswell known in the art can be used with comparable results. apressure-sensitive resin solution of low-molecular weight acrylicpolymer has proven quite satisfactory. Care must be taken, of course, inthe selection of a suitable adhesive to insure that it is free of skinirritants and, especially, that it is non-toxic for the reason that itwill ultimately lie closely adjacent a stoma opening directly in to theuse rs colon. Such adhesives are, of course, widely used on bandagingmaterials and the like already.

Undoubtedly, the most important single feature of the invention is thenon-woven fibrous material used as a base for the patch 42. Excellentresults have been obtained by using as the base fabric the 0.3 ounce persquare yard spunbonded Nylon" sold by Monsanto Chemical Company underthe trademark Cerex." This fabric and others like it comprises an openporous network of randomly-laid fibers bonded together at their pointsof intersection to define sheets that can be obtained in varyingthicknesses and porosities. For purposes of the present invention, thedesired characteristics of the fabric are, first of all, the tensilestrength it supplies to the pressure-sensitive patch. In other words. apressure-sensitive non-drying adhesive applied directly to the rear faceof either the bag or carrier for purposes of fastening the latter to thehuman body in the manner of ordinary adhesive tape or the like, isunsatisfactory because the adhesive has far too little tensile strength.When laminated with the non-woven fibrous material on the other hand,the patch thus produced provides the missing tensile strength necessaryfor good retention.

Secondly, the patch is thin and provides excellent conformity with theirregular surface of the user's body to which it is attached. This.together with its ability to flex and stretch in all directions towhatever degree necessary to accommodate the movements of the skintherebeneath are also most important criteria.

Third, due to the random lay of the fibers from which the fabric isconstituted, it has the ability to breathe" through the edges thereofand thus considerably reduce, if not eliminate altogether. skinirritation beneath the patch that is ordinarily encountered. This occurseven though the inside (exposed) face 48 of the patch is tightly sealedagainst the wearer's body and the outside (hidden) face 54 is similarlysealed against the non-porous bag or carrier therefor.

Finally, the base fabric must be soft. pliable and nontoxic so as to notcontribute to any irritation of the skin over which it is laid nor tointroduce any impurities into the body through the stoma it borders.While other fabrics commonly employed as bandaging materials such as,for example, gauze and the like, possess some of these same properties,they are woven and, therefore, do not possess the same ability toconform, breathe and stretch in all directions as the non-woven fabricpreferred herein. Furthermore, woven fabrics are characteristically manytimes thicker.

The rip-strip 50 is of conventional design and preferably comprises asilicone-coated paper having a release factor as determined by a Keiltester of somewhere around to 80 grams per inch of strip width. Whileother types of rip-strips can be substituted for the silicone-coatedpaper type with comparable results, the latter type has proven quitesatisfactory.

in order to use the appliance, the user need only remove the rip-stripfrom the exposed face 48 of the patch 42, cut a hole in the rear wall ofthe bag of the same size as the body opening and fasten the unit inplace. if desired, the patch could, perhaps, be prepunched in whichevent the opening thus formed could be employed as a template to assistthe user in cutting a registering hole in the bag.

Next, with reference to FIG. 4, reference numeral 56 shows arepresentative bag carrier of the type that is strapped oradhesively-attached to the wearers body over the opening thereinpreparatory to hanging the disposable bags therefrom. The rear face 58shown is the one that lies next to the wearers skin and is, therefore,the only one that concerns us here. The front face (not shown)customarily has some kind of marginal flange or lip bordering theopening 60 therethrough to which the open neck of a suitably-shapeddisposable bag is detachably connected and held in place by an elasticband, clip or some such fastening means.

For present purposes, all that concerns us here is the rear face 58 towhich is adhesively attached the doublefaced patch 42.

The patch 42m is supplied to the user in the form of a laminatedsubassembly which differs slightly from the laminate 12 of FIGS. 1, 2and 3 that fastens the bag directly to the wearer's body in that it hasa shape adapted to mate with the carrier 56 to be used therewith and.secondly, its hidden face is also left covered by a rip-strip 501: untiljust before use. In order to attach the carrier to the body. the usersimply removes the rip-strip 50h from the hidden face of the patch 42mand sticks the latter on the rear face 58 of the carrier. Then, thesecond rip-strip SOe is removed from the exposed face 48 of the patch42m preparatory to fastening the assembly thus formed to the body. Acorner of the patch 42m is preferably covered permanently by a small tab52 so as to facilitate removal of the rip-strips therefrom as well asthe patch itself from both the body and carrier following use.

Finally, with reference to H0. 5, the novel method of making thelaminate has been shown schematically. The extremely thin character ofthe non-woven fabric 62 from which the patch 42 is fabricated renders itunsuitable for applying adhesive-coatings thereto by the usual methods.While the fabric can be dipped in adhesive, the resulting patch isrendered essentially nonporous due to the interstices between the fibersbeing filled with the latter. Furthermore, the resulting patch is stiff,less elastic, somewhat more abrasive and generally less suitable allaround. Accordingly, it has been discovered that the best way ofpreserving the desirable characteristics inherent in the non-wovenfabric that render it ideally suited for use in the instant applicationis to not coat the adhesive 64 on the fabric directly. but instead,indirectly by coating the releasable surfaces 66 of the rip-strips 5011and 5012 therewith preparatory to sandwiching the uncoated fabric 62therebetween. This unique method of forming the laminate is representedin FIG. 5 by the pinch rollers 68 which are shown squeezing a layer ofthe uncoated non-woven fabric 62 between two sheets ofsilicone-impregnated rip-strip 501i and 50a to the opposed releasablesurfaces 66 of which has been applied a coating of the non-dryingpressure-sensitive adhesive 64. The procedure of sandwiching theuncoated fabric between the adhesivecoated sheets of rip-strip transfersthe adhesive to the fabric thus forming the patch 42. When therip-strips are removed, the adhesive stays with the fabric due to itssubstantially greater retention ability or affinity for the latter.

What is claimed is:

l. The colostomy appliance which comprises: a fluidtight flexible bagclosed at its lower end, a thin pliable fabric patch of stretchablenon-woven fibrous material fixedly attached to the rear wall of the bag.a layer of non-drying pressure-sensitive adhesive coating the exposedface of the patch, and a silicone impregnated ripstrip overlying theadhesive-coated face of the patch defining a removable protective covertherefor.

2. The colostomy appliance as set forth in claim 1 in which: the thepatch is porous.

3. The colostomy appliance as set forth in claim 1 in which: thenon-woven fibrous material is capable of stretching to a limited degreein all directions.

4. The colostomy appliance as set forth in claim 2 in which: the patchis of a thickness effective where attached to the body of the wearer tohold the bag in spaced relation thereto and permit air to circulatetherebetween.

1. THE COLOSTOMY APPLIANCE WHICH COMPRISES: A FLUID-TIGHT FLEXIBLE BAGCLOSED AT ITS LOWER END, A THIN PLIABLE FABRIC PATCH OF STRETCHABLENON-WOVEN FIBROUS MATERIAL FIXEDLY ATTACHED TO THE REAR WALL OF THE BAG,A LAYER OF NON-DRYING PRESSURE-SENSITIVE ADHESIVE COATING THE EXPOSEDFACE OF THE PATCH, AND A SILICONE IMPREGNATED RIP-STRIP OVERLYING THEADHESIVE-COATED FACE OF THE PATCH DEFINING A REMOVABLE PROTECTIVE COVERTHEREFOR.
 2. The colostomy appliance as set forth in claim 1 in which:the the patch is porous.
 3. The colostomy appliance as set forth inclaim 1 in which: the non-woven fibrous material is capable ofstretching to a limited degree in all directions.
 4. The colostomyappliance as set forth in claim 2 in which: the patch is of a thicknesseffective where attached to the body of the wearer to hold the bag inspaced relation thereto and permit air to circulate therebetween.